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| HHS/FDA | RIN: 0910-AC55 | Publication ID: Spring 2008 |
| Title: Positron Emission Tomography Drugs; Current Good Manufacturing Practices | |
| Abstract: Section 121 of the Food and Drug Administration Modernization Act of 1997 (Pub. L. 105-115) directs FDA to establish requirements for current good manufacturing practices (CGMPs) for positron emission tomography (PET) drugs, a type of radiopharmaceutical. The proposed rule would adopt CGMPs that reflect the unique characteristics of PET drugs. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Final Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 212 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: PL 105-115, sec 121 | |
Legal Deadline:
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Timetable:
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| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: Federal, State |
| Small Entities Affected: Governmental Jurisdictions | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Information URL: www.fda.gov/cder/regulatory/pet | |
| RIN Data Printed in the FR: Yes | |
| Related RINs: Previously reported as 0910-AB63 | |
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Agency Contact: Brian L. Pendleton Senior Policy Advisor Department of Health and Human Services Food and Drug Administration Suite 3037 (HFD-7), Office of Policy, 10903 New Hampshire Avenue, Building 1, Room 4324, Silver Spring, MD 20993-0002 Phone:301 796-4614 Fax:301 847-3541 Email: brian.pendleton@fda.hhs.gov |
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